Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters
FDA 510(k) K171043 · Coloplast Corp.
510(k) numberK171043
Submission
- Device name
- Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters
- Applicant
- Coloplast Corp.
Plymouth, MN, US - Received
- April 7, 2017
- Decision date
- December 21, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EYB – Catheter, Ureteral, Gastro-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
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|---|---|---|---|
| K192183 | RocaTub Ureteral CatheterEYB · Traditional | Promepal Sam | 04/23/2020SE |
| K191187 | Dornier MINNOW Ureteral CatheterEYB · Traditional | Dornier Medtech America, Inc. | 09/18/2019SE |
| K183323 | UPJ Occlusion Balloon CatheterEYB · Traditional | Cook Incorporated | 08/05/2019SESK |
| K182695 | Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral CatheterEYB · Traditional | Cook Incorporated | 06/17/2019SESK |
| K182122 | Ureteric CathetersEYB · Traditional | Coloplast Corp. | 10/04/2018SE |
| K180182 | Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access CatheterEYB · Traditional | Cook Incorporated | 09/14/2018SE |
| K133750 | Occluder Occlusion Balloon CatheterEYB · Traditional | Boston Scientific Corporation | 01/08/2014SE |
| K092250 | Medline Red Rubber Urethral CatheterEYB · Traditional | Medline Industries, Inc. | 01/21/2010SE |
| K083788 | Endo Optiks Urological Catheter for Endoscopy, Model SessrEYB · Traditional | Endooptiks, Inc. | 03/03/2009SE |
| K043581 | Dual Lumen CatheterEYB · Special | Acmi Corporation | 03/03/2005SE |
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| K242049 | SureCath SetEZD · Traditional | 11/26/2024SE |
| K241210 | Luja CoudeEZD · Traditional | 11/21/2024SE |
| K242173 | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10…FED · Traditional | 11/12/2024SE |
| K242473 | Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551)…PAH · Traditional | 10/18/2024SE |
| K241028 | Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)EZD · Traditional | 07/26/2024SE |
| K233411 | Folysil Silicone CatheterEZL · Traditional | 04/15/2024SE |
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Questions and answers
When was Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters cleared by the FDA?
Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters (K171043) received a 510(k) decision of Substantially Equivalent on December 21, 2017, 258 days after the submission was received.
What is the product code of K171043?
The FDA product code is EYB – Catheter, Ureteral, Gastro-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.5130.